Prothrombotic Biomarkers and Ovarian Stimulation

Sterility, Female Clinical Trial

— HEMOSTIM  

Official title:

Thrombotic Profile of Ovarian Stimulation Protocols in Reproductive Medical Assistance: a Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04188444
• Other study ID #: CCER2019-02134
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: September 30, 2020

Study information

• Verified date: November 2020
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to assess the impact of different protocols used for ovarian stimulation during in vitro fertilization procedures (IVF) on prothrombotic biomarkers (blood coagulation markers associated with thromboembolic events) in the units of reproductive medicine in two university hospitals (HUG, Geneva and CHUV, Lausanne).

Description:

HEMO-STIM is a prospective multicentric cohort study of subfertile women undergoing ART. It is an epidemiologic observational study. All women older than 18 years attending the reproductive medicine unit (UMREG, Geneva, HUG or UMR, Lausanne, CHUV) and undergoing an IVF have been and will be recruited consecutively and included. The type of stimulation protocol used is recorded.

All measurements (specific haemostasis test with a thrombin generation assay before and after adjunction of APC) that are part of the study will be performed in the HUG laboratories in order to limit inter-dosage variability.

The 1st blood test will be performed at inclusion in the absence of any hormonal treatment (T1). A 2nd blood test will be performed on the day of ovulation triggering (T2). A 3rd blood test will be performed 7 days after ovulation triggering (T3).

The comparison of different protocols has never been performed and data on the effect of antagonist protocols for IVF on haemostasis are lacking. The measurement of intermediate biomarkers of thromboembolic risk during different IVF stimulation protocols (agonists and antagonists) would allow the comparison of their thrombotic profile and to optimize the risk/benefit ratio during ART by prescribing protocols at lower vascular risk, in particular in women identified as being at risk for thromboembolic events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: September 30, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

Inclusion Criteria:

• Women older than 18 years

• Sub-fertile and undergoing IVF

Exclusion Criteria:

• >43 years old

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Reproductive Technology, Assisted
• Sterility, Female

Intervention

Biological:
• Blood test
20 ml of blood, three times

Locations

Country	Name	City	State
Switzerland	University Hospitals of Geneva	Geneva
Switzerland	CHUV	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in normalized APC sensitivity ratio	Haemostasis parameters: thrombin Generation Assay	T1: inclusion; T2: day1 ovarian stimulation; T3: day7 after ovarian stimulation
Secondary	Change in fibrinolysis assay	haemostasis parameters: turbidimetry assay	T1: inclusion; T2: day1 ovarian stimulation; T3: day7 after ovarian stimulation